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Test for reproductive and developmental toxicity of medical devices—Part 1:Screening test
Standard in brief
Scope of Application:
YY/T 1292的本部分规定了医疗器械或材料生殖和发育毒性筛选试验方法。
本部分适用于医疗器械或材料生殖和发育毒性试验。
Basic information
Standard No:YY/T 1292.1-2015
Standard Name:医疗器械生殖和发育毒性试验 第1部分:筛选试验
English Name:Test for reproductive and developmental toxicity of medical devices—Part 1:Screening test
Standard Status:现行
Release Date:2015-03-02
Effective Date:2016-01-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.040.01
CCS Number:C30
Related Standards
Referenced Standards:GB/T 16886.1,GB/T 16886.2,GB/T 16886.3,GB/T 16886.12
Publication Information
Number of pages:16
Number of words:22 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2015-06-01
Standard Revision Information
Has Amendment:No
Other Information
Application Dept:国家食品药品监督管理总局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:1292.1
Drafter:侯丽、乔春霞、曹苹、叶向锋
Drafting Organization:国家食品药品监督管理局济南医疗器械质量监督检验中心、深圳市医疗器械检测中心、中国医学科学院北京协和医学院新药安全评价研究中心
Management Organization:全国医疗器械生物学评价标准化技术委员会(SAC/TC 248)
Proposing Department:国家食品药品监督管理总局